Academisch Medisch Centrum - Universiteit van Amsterdam
Amsterdam, Netherlands
NCT Number: NCT04593797
Rationale: Diligent fluid management is instrumental to improve postoperative outcome, cost and quality of care.
Objective: To determine the accuracy of brachial, femoral and carotid blood flow measurement with ultrasound compared to intermittent transpulmonary thermodilution cardiac output measurement, invasive and non-invasive pulse-contour analysis.
Study design: Observational study - Prospective clinical non-intervention measurement study.
Study population: Adult ASA 1-2 patients, scheduled for open upper GI surgery Intervention (if applicable): Not applicable. We will perform non-invasive ultrasound measurements of the femoral, carotid and brachial blood flow right before induction and under anaesthesia.
Main study parameters/endpoints: Femoral, carotid and brachial blood flow determined by ultrasound and blood flow variation and the accuracy compared to transpulmonary thermodilution cardiac output, stroke volume variation, and pulse-contour analysis derived cardiac output (invasive or non-invasive) at the following time points during surgery; (limited for femoral site as it cannot be measured during surgery): (1) before induction of anaesthesia, (2) after induction, (3) 15 minutes after start of surgery, (4) before and (5) after (1-2 minutes) a fluid bolus, (6) before and (7) after start of vasopressors, (8) before and (9) after Trendelenburg position and (10) after surgery before end of anaesthesia (figure 1). A fluid bolus will be performed as part of standard care (goal-directed fluid therapy). The vasopressor and Trendelenburg position time points are optional measurements. We will also measure (continuous) invasive femoral blood pressure (SBP, DBP, MAP), non-invasive blood pressure, SVV, central venous pressure (when available), heart rate, SpO2, PFI, etCO2.
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Notify Me18 year and older
All sexes
Observational
Amsterdam, Netherlands
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
carotid blood flow measurement with ultrasound vs transpulmonary thermodilution calibrated continuous cardiac output measurements
Other names: transpulmonary thermodilution calibrated continuous cardiac output measurements
Time frame: baseline
blood flow determined by ultrasound and the accuracy compared to transpulmonary thermodilution calibrated continuous cardiac output
Time frame: change from baseline cardiac output 1 minute after intervention (fluid challenge, vasopressor administration, or Trendelenburg)
Change in blood flow compared to change in cardiac output
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Other
The Accuracy of Ultrasound Derived Carotid, Femoral and Brachial Artery Compared to Conventional Intra-vascular Methods Flow-related Parameters
Acronym: EFLOW
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